The International Council for Harmonisation (ICH): 'E' group of guidelines

Below is the overview of 'E' group of ICH guidelines that collectively apply to different stages and types of pre- / clinical research and development.

 

ICH: ‘E’ group of guidelines overview

 

General Considerations for Clinical Studies:

E 8 (R1) ICH Consensus Guideline

 

Design and Analysis:

E4 Dose-Response Studies

E9 Statistical principles for Clinical Trials

E10 Choice of Control Group in Clinical Trials

E17 Multi-Regional Clinical Trials

Conduct and Reporting:

E3 Clinical Study Reports

E6 Good Clinical Practice

Safety Reporting:

E1 Clinical Safety for Drugs used in Long-Term Treatment

E2A – E2F Pharmacovigilance

E14 Clinical Evaluation of QT

E19 Safety Data Collection

 

Populations:

E5 Ethnic Factors

E7 Clinical Trials in Geriatric Population

E11 – E11A Clinical Trials in Pediatric Polulations

E12 Clinical Evaluation by Therapeutic Category

Genetics / Genomics

E15 Definitions in Pharmacogenetics/Pharmacogenomics

E16 Qualification of Genomic Biomarkers

E18 Genomic Sampling

 

Other EU Guidelines:

Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

 

 

Author: European Medicines Agency

Clinical Research News

Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products
Submission of comments on ICH E6 (R3) Guideline for Good Clinical Practice(GCP) - Step 2b 
ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation
The study of the new investigational drug for acute myeloid leukemia and myelodysplastic syndrome
Open Label study of entrectinib in ROS1 gene fusion-positive rare adult, paediatric and teenage/young adult cancers
Gasherbrum Bio, Inc is starting the study of GSBR-1290 drug in overweight or obese healthy adults
A new study of Dexpramipexole in adolescents and adults with severe Eosinophilic Asthma

Upcoming Clinical Research Events

All events

Kommande kliniska prövningar

Clinical Research Jobs

All jobs
Prenumerera

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner